Job Information
Teva Pharmaceuticals Senior Director, Regulatory Affairs II in West Chester, Pennsylvania
Senior Director, Regulatory Affairs II
Date: Apr 20, 2024
Location:
West Chester, United States, Pennsylvania, 19380
Company: Teva Pharmaceuticals
Job Id: 54239
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Senior Director, Regulatory Affairs II will have a knowledge of global industry initiatives and direction and has ability to represent Teva at industry/association meetings. Will understands Teva’s vision and contributes to driving GRO forward to meet company goals. Has the ability to inspire and lead teams to fullest potential in a positive approach and a “can do” attitude. Allocates appropriate resources to support submission activities and oversees the coordination and support of major submissions. Develops SOPs as well as involvement in the development of publishing standards and practices. Leads major project teams for Teva and/or industry initiatives. Builds relationships with regional/global RA staff and authoring sites to ensure alignment on submission deliverables and timelines. Knows when to escalate project/system issues to the appropriate levels. Manages goal setting and development plans for staff and serves as a mentor. Provides leadership and direction for cross functional groups (both internally within GRO and across multiple Teva functions) in order to support global initiatives such as Pivot to Growth and other key projects in order to driver Teva to success in meeting its key performance indicators and support continued growth of the company specifically with regards to support of the innovative portfolio.
How you’ll spend your day
Manage resources to support submission activities for responsible sites and oversees the coordination and delivery of major submissions to directly support the companies growth strategy.
Build relationships with RA staff/authoring sites to ensure alignment on submission deliverables and timelines and serve as a liaison in stakeholder management.
Participate in Global Regulatory Operations management team meetings.
Leads major Global Regulatory Affairs project teams.
Develop functional SOPs as well as internal publishing standards and practices.
Follows Teva Safety, Health, and Environmental policies and procedures.
Other projects and duties as required/assigned.
Your experience and qualifications
Requires a minimum of a Bachelor’s Degree in Life Sciences or Information Technology, would prefer an advanced degree in scientific or information technology discipline.
Requires a minimum of 10-20 years in Regulatory Operations/Regulatory Affairs, would prefer experience with leading a Regulatory Operations team.
Requires advanced knowledge and understanding of regulatory systems and processes designed to support day to day processes i.e eCTD submission platforms, integrated data management solutions and submission management and document processing tools.
Requires advanced understanding of IT infrastructure and how systems are integrated to support day to day regulatory and submission publishing business processes with a expert functional knowledge of regulatory process design.
Requires an in depth understanding of the drug development process. Knowledge of generic, innovative and biosimilar development processes and requirements is essential.
Requires detailed knowledge of industry legislation and best practices.
Requires expert knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper).
Enjoy a more rewarding choice
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.
Reports To
VP Global Regulatory Affairs
Already Working @TEVA?
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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EOE including disability/veteran